Status:
UNKNOWN
Tracking Response to Antidepressants in Advance of Investigational Trials
Lead Sponsor:
Adams Clinical
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Brief Summary
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals ...
Eligibility Criteria
Inclusion
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant is male or female of age ≥ 18 years old.
- Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
- Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.
Exclusion
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- Participant has a history of any psychiatric condition other than MDD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- Any participant who represents an acute suicidal risk in the opinion of the investigator.
- Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
- Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
Key Trial Info
Start Date :
January 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04748276
Start Date
January 2 2019
End Date
December 31 2023
Last Update
March 27 2023
Active Locations (1)
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1
Adams Clinical
Watertown, Massachusetts, United States, 02472